ARTELAC 0.32% W/V EYE DROPS SINGLE DOSE UNIT - summary of medicine characteristics

Artelac 0.32% w/v Eye Drops Single Dose Unit

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Hypromellose, 0.32% w/v

Excipients with known effect

Disodium phosphate dodecahydrate an d Sodium dihydrogen phosphate dihydrate (0.068 mg phosphates in each drop which is equivalent to 1.84 mg/ml)

For full list of excipients, see 6.1.

4   CLINICAL PARTICULARS

4.1 Therapeutic indications

This medicinal product acts as a lubricant and artificial tear in the symptomatic treatment of dehydration of the cornea and conjunctiva due to impaired lacrimal secretion and functional disorders as a result of topical or systemic diseases, or caused by deficient or incomplete eyelid closure.

Artelac 0.32% w/v Eye Drops Single Dose Unit is indicated in adults and children.

4.2 Posology and method of administration

Posology

Suitable for use in adults and children.

Unless otherwise directed, instill 1 drop into the conjunctival sac (corner of the eye, nearest the nose) 3 to 5 times per day or as required, to provide sufficient lubrication.

Therapy of dry eye syndrome requires an individual dosage regimen.

Leave an interval of at least 5 minutes before instilling another ophthalmic Medication

Method of administration

For ocular use only

4.3 Contraindications

Hypersensitivity to the active substance (hypromellose) or to any of the excipients Listed in section 6.1.

4.4 Special warnings and precautions for use

Stop treatment and consult a physician if irritation persists or worsens or new eye signs or symptoms develop. Wearers of soft contact lenses should remove their lenses before Artelac 0.32% w/v Eye Drops Single Dose Unit is administered and should wait for at least 15 minutes before they insert them again.

Important information about the ingredients of this medicine:

This medicine contains disodium phosphate dodecahydrate and sodium dihydrogen phosphate dihydrate (0.068 mg phosphates in each drop which is equivalent to 1.84 mg/ml). If you suffer from severe damage to the clear layer at the front of the eye (the cornea), phosphates may cause in very rare cases cloudy patches on the cornea due to calcium build-up during treatment.

4.5 Interaction with other medicinal products and other forms of interaction

None

4.6 Fertility, pregnancy and lactation

Pregnancy

Artelac 0.32% w/v Eye Drops Single Dose Unit can be used during pregnancy

Breast-feeding

Artelac 0.32% w/v Eye Drops Single Dose Unit can be used in lactation.

Fertility

Artelac 0.32% w/v Eye Drops Single Dose Unit is not expected to have any effect on fertility.

4.7 Effects on ability to drive and use machines

Artelac 0.32% w/v Eye Drops Single Dose Unit on instillation may cause a short term blurring of vision when first used. If affected wait until vision has cleared before driving or operating machinery.

4.8 Undesirable effects

The following adverse reactions have been reported following administration of Artelac 0.32% w/v Eye Drops Single Dose Unit.

Very rare (<1/10,000 ):

Cases of corneal calcification have been reported very rarely in association with the use of phosphate containing eye drops in some patients with significantly damaged corneas.

Not known:

Brief blurred vision or a slight stinging sensation on instilling Artelac 0.32% w/v Eye Drops Single Dose Unit.

Reporting of suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard

4.9 Overdose

No case of overdose has been reported

5.1

Pharmacotherapeutic group:

Ophthalmologicals: other ophthalmologicals

ATC code: S01X A20

Hypromellose prolongs adhesion, enhances moistening of the cornea and conjunctiva and allows for a smoother movement of the conjunctiva over the cornea.

5.2 Pharmacokinetic properties

Hypromellose does not permeate the cornea or reach the systemic circulation via the ophthalmic vessels.

5.3 Preclinical safety data

There is no preclinical data of relevance to the prescriber.

6.1

Disodium phosphate dodecahydrate

Sodium dihydrogen phosphate dihydrate Sorbitol

Purified water

6.2

Not applicable

6.3

Shelf life

6.4 Special precautions for storage

Do not store above 25°C.

6.5 Nature and contents of container

0.5 ml single dose unit, composed of LDPE.

30, 60 and 120 single dose units

6.6 Special precautions for disposal

Avoid contamination during use. Artelac SDU eye drops are sterile until first opened.

For single use only. Each carton contains a patient insert with instructions for use.

7 MARKETING AUTHORISATION HOLDER

Bausch & Lomb (UK) Ltd

Bausch &Lomb House

106 London Road

Kingston-Upon-Thames

Surrey KT2 6TN

UK

8 MARKETING AUTHORISATION NUMBER(S)

PL 03468/0033